Recall Z-2735-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
| Date | Aug 27, 2024 (initiated May 22, 2024) |
| Status | Open, Classified |
| Reason | When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 5/16/2024 on 5/22/2024 via postal mail and email notification. The letter described the issue, impact, action, and resolution. Beckman Coulter will implement the correction with a future software release and the consignee will be contacted by their Beckman Coulter service representative to schedule the software upgrade. If the device has been forwarded to another laboratory, the consignee is requested to provide a copy of the letter to that location. A response was requested within 10 days electronically via email or through completion and return of t |
| Quantity | 183 analyzers |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.